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Last Updated: March 19, 2024

Zolpidem tartrate - Generic Drug Details


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What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Almatica, Aytu, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Breckenridge, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys, Mylan, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty-two NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has one hundred and forty-one patent family members in twenty-three countries.

There are thirty-two drug master file entries for zolpidem tartrate. Forty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for zolpidem tartrate

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Drug Sales Revenue Trends for zolpidem tartrate

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Recent Clinical Trials for zolpidem tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 4
National Institute on Aging (NIA)Phase 4
University of PennsylvaniaPhase 4

See all zolpidem tartrate clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INTERMEZZO Sublingual Tablets zolpidem tartrate 1.75 mg and 3.5 mg 022328 1 2012-04-10
EDLUAR Sublingual Tablets zolpidem tartrate 5 mg and 10 mg 021997 1 2010-04-29
AMBIEN CR Extended-release Tablets zolpidem tartrate 6.25 mg 021774 1 2006-02-24
AMBIEN CR Extended-release Tablets zolpidem tartrate 12.5 mg 021774 1 2006-01-19

US Patents and Regulatory Information for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077903-002 Aug 17, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Invagen Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078184-002 Sep 7, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novel Labs Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 204299-002 Jun 3, 2015 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acme Labs ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077214-002 Apr 23, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Form ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 201509-001 Aug 1, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078616-001 Nov 21, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Anchen Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 078148-001 Dec 3, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Aytu ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for zolpidem tartrate

Country Patent Number Title Estimated Expiration
Australia 4894697 Buccal, polar and non-polar spray or capsule ⤷  Try a Trial
European Patent Office 1675567 SPRAY NON POLAIRE, POLAIRE ET BUCCAL CONTENANT DU SUMATRIPTAN (BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING SUMATRIPTAN) ⤷  Try a Trial
Portugal 2340872 ⤷  Try a Trial
Japan 2006502150 ⤷  Try a Trial
European Patent Office 1750670 PULVERISATEUR BUCCAL, POLAIRE ET NON POLAIRE CONTENANT DU PROPOFOL (BUCCAL, POLAR AND NON-POLAR SPRAYS CONTAINING PROPOFOL) ⤷  Try a Trial
South Korea 20060090997 BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING ONDANSETRON ⤷  Try a Trial
European Patent Office 1534242 VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR TRAITER DES MALADIES DES VOIES GASTRO-INTESTINALES OU DES VOIES URINAIRES (BUCCAL, POLAR OR NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING DISORDERS OF THE GASTROINTESTINAL TRACT OR URINARY TRACT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for zolpidem tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 CA 2015 00004 Denmark ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132 C300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 122015000006 Germany ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 92636 Luxembourg ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.